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Impact of Atelectasis on RVEDP Following Orthotropic Heart Transplantation

NCT ID: NCT06140810

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-20

Study Completion Date

2024-11-01

Brief Summary

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Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements to guide post transplant treatment regiments. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection.

Detailed Description

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Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). Atalectaisis is known to alter intra-thoracic pressures and cardiac loading conditions. What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection. Therefore, the aim of this study is to identify if atelectasis impacts the pressure measurements obtained during cardiac catheterization.

Conditions

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Heart Transplant Failure Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Right ventricular End diastolic pressure

Measurement of pre and post recruitment right ventricular end diastolic pressure

Lung Recruitment

Intervention Type OTHER

Lung Recruitment will be performed during general anesthesia to reduce areas of atelectasis

Interventions

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Lung Recruitment

Lung Recruitment will be performed during general anesthesia to reduce areas of atelectasis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients having undergone orthotropic heart transplantation
* Patients requiring routine heart catheterization for post-transplant surveillance
* General anesthesia

Exclusion Criteria

* Patient/parental refusal
* Patients with suspected or known acute rejection
* Known anti-rejection medication non-compliance
* Patients within 1 year following heart transplant
* Home oxygen requirement
* Previous lung surgery (e.g., lobectomy) other than biopsy
* Lung transplantation
* Known pulmonary fibrosis
* Known pulmonary hypertension (\>1/2 systemic)
* Sedation without the use of an airway device
* Active respiratory infection -Inability to provide recruitment breaths \>25mmHg -Cardiomegaly
* Recipient/donor size mismatch
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Adam Adler MD, MS, FAAP

Associate Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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adam adker, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Childrens Hospital

Locations

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Texas Childrens Hospital

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam Adler, MD

Role: CONTACT

Phone: 8328245800

Email: [email protected]

Facility Contacts

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Adam Adler, MD

Role: primary

Other Identifiers

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H52547

Identifier Type: -

Identifier Source: org_study_id